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Design and outcomes of a nurse practitioner preceptor development program

Hallas, Donna; Haber, Judith; Biesecker, Babette; Hartnett, Erin; Toft Klar, Robin; Djukic, Maja; Apold, Susan; Vetter, Mary Jo; McMillan, Adrienne; Brilliant, Maria; Baldyga, Julie A; Waingortin, Ryan; Fletcher, Jason
ABSTRACT/UNASSIGNED:Nurse practitioners (NPs) are educated to provide high-quality patient- and family-centered care to underserved, culturally diverse, medically complex populations. Nurse practitioner faculty plan curricular activities that challenge NP students to critically assess individuals and populations with the goal of preparing NP students to be "practice-ready" upon graduation. Nurse practitioner clinical training occurs in practice settings with NP preceptors, with specific areas of clinical expertise. However, there is a lack of NP clinical preceptors educationally prepared to clinically teach and evaluate NP students. This article presents the design, implementation, evaluation, and outcomes from a 3-year grant funded by the United States Human Resources and Administration Services that featured a web-based Primary Care Nurse Practitioner Preceptor Development Program. Ninety percent of NPs who precepted NP students completed all web-based learning modules. Preceptors with educational preparation via online modules to guide NP student learning in clinical settings are a critical resource for faculty to prepare NP students to be practice-ready upon graduation. This web-based learning platform for online NP preceptor education may be a successful approach for expanding and improving the NP preceptor pool nationwide.
PMID: 33731555
ISSN: 2327-6924
CID: 4817902

Phase Ib/II trial of polatuzumab vedotin plus obinutuzumab and lenalidomide in patients with relapsed/refractory follicular lymphoma: Primary analysis of the full efficacy population [Meeting Abstract]

Diefenbach, C S; McMillan, A; Kahl, B S; Miall, F; Banerjee, L; Briones, J; Cordoba, R; Abrisqueta, P; Hirata, J; Chang, Y; Musick, L
In a Phase Ib/II trial of patients (pts) with relapsed/refractory follicular lymphoma (R/R FL), polatuzumab vedotin (Pola) + obinutuzumab (G) showed activity and tolerability (Phillips et al. Blood 2016). A Phase II study of the doublet combination of G + lenalidomide (Len) showed activity and acceptable safety in pts with R/R FL (Morschhauser et al. Lancet 2019). Here, we present the full primary analysis of efficacy and safety of Pola-G-Len in pts with R/R FL from the Phase Ib/II study, GO29834 (NCT02600897). GO29834 is an open-label, multicentre study of pts with R/R FL (Grade <3b) who had received >=1 prior anti-CD20-containing chemo-immunotherapy regimen. The recommended Phase II dose (RP2D) for Pola+Len was defined in a 3+3 dose-escalation phase. In the Phase II expansion cohort, pts received induction treatment with six 28-day cycles of: G 1000 mg IV (Cycle [C]1: Day [D]1, D8, D15; C2-6: D1); Pola 1.4 mg/kg IV (D1), Len 20 mg PO (D1-21). Responders received maintenance treatment for 24 months: G 1000 mg (D1 every 2 months); Len 10 mg (D1-21, Months 1-12). The primary endpoint was Independent Review Committee (IRC)-assessed complete response (CR) at end of induction (EOI), based on positron emission tomography-computed tomography (PET-CT) scans (modified Lugano 2014 criteria). Progression-free survival (PFS) was assessed by the investigator. As of 12 August 2019, 56 pts were enrolled and had entered induction (Phase Ib/II cohorts); median follow-up was 16.6 and 15.1 months in safety- and efficacy-evaluable populations, respectively. Baseline characteristics were: median age, 62 years; male, 59%; Ann Arbor Stage III-IV, 88%; Follicular Lymphoma International Prognostic Index high-risk (>=3), 55%; bulky disease (>=7 cm), 16%; >=2 prior lines of therapy, 77%; refractory to last line of prior therapy/ any anti-CD20 treatment, 59%/71%, respectively. All pts had >=1 adverse event (AE), 32 (57%) had a serious AE, 47 (84%) had a Grade 3-4 AE. The most common Grade 3-4 AEs were neutropenia (n = 31, 55%), thrombocytopenia (n = 15, 27%), infections (n = 11, 20%), and anaemia (n = 8, 14%). AEs led to dose reduction or interruption of any drug in 19 (34%) and 43 (77%) of pts, respectively; the majority were modifications of Len. AEs led to the discontinuation of any study drug in 17 (30%) pts. One Grade 5 AE was reported (septic shock); this was not considered study treatmentrelated as the pt was receiving a new anti-lymphoma treatment following disease progression (PD). In the primary efficacy population (n = 46), the IRC-assessed objective response rate was 76%, the CR rate was 63% (Table). Subgroup analysis showed that 60% (15/25) of pts who were refractory to their last treatment achieved a CR. Median PFS was not reached. Our study of the novel triplet combination, Pola-G-Len demonstrates a safety profile consistent with the known profiles of the individual drugs. CR rates at EOI were high in this heavily pre-treated and refractory population, which compares favourably with currently available R/R FL therapies. These findings support further investigation of Pola-G-Len in a larger pt population. Follow-up is ongoing to determine the median PFS
EMBASE:633022555
ISSN: 1365-2141
CID: 4635772

Polatuzumab vedotin (POLA) + obinutuzumab (G) + lenalidomide (LEN) in patients (pts) with relapsed/refractory (R/R) follicular lymphoma (FL): Phase Ib/II interim analysis [Meeting Abstract]

Diefenbach, C; Kahl, B; Banerjee, L; McMillan, A; Ramchandren, R; Miall, F; Briones, J; Cordoba, R; Gonzalez-Barca, E; Panizo, C; Hirata, J; Chang, N; Musick, L; Abrisqueta, P
Introduction: Pola-G-Len may enhance anti-tumor immune response in R/R FL. We report a pre-planned interim analysis of the safety/efficacy of induction and maintenance with Pola-G-Len in pts with R/R FL in a phase Ib/II study (NCT02600897).
Method(s): Pts received induction treatment with 6x 28-day (D) cycles (C) of: G 1000mg IV (C1: D1, D8, D15; C2-6: D1); Pola 1.4mg/kg or 1.8mg/kg dose escalation (DE) or recommended phase 2 dose (RP2D; expansion) IV (D1); and Len 10-20mg (DE) or RP2D (expansion) PO (D1-21). Pts with complete response (CR)/partial response (PR)/stable disease (SD) at the end of induction (EOI) received G 1000mg (D1 every 2mo, for 24mo), and Len (10mg, D1-21 monthly, 12mo). Primary endpoints were C1 dose-limiting toxicities (DLTs), safety/tolerability, CR rate at EOI (modified Lugano criteria). Results At the interim data cut-off (6 July 2018), 52 pts were enrolled: 9 discontinued the study (adverse events [AE], n=3; death due to PD, n=4; pt withdrawal, n=1; other, n=1). At baseline, the median pt age was 62 (range 32-87) years; 60% were male; 58% had FLIPI score 3-5; 79% had received >=2 prior therapy lines; 50% were refractory to their last treatment; 17% had bulky disease (>=7cm). Two DLTs were reported in the cohort receiving Pola 1.8mg/kg + Len 10mg during the DE period (Gr 4 lipase/amylase elevation; asymptomatic, resolved with supportive care; Gr 3 thrombocytopenia leading to a delay in the initiation of cycle 2). Gr >=3 AEs were experienced by 75% of pts: neutropenia (46%), thrombocytopenia (17%), anemia (12%) and infections (12%) were the most common AEs. Len dose reduction or interruption occurred in 31% and 52% of pts, respectively. One Gr 5 AE was reported (septic shock after PD in pt receiving subsequent therapy). The RP2D was determined as Pola 1.4mg/kg + Len 20mg. Preliminary efficacy data suggest high activity, with an independent review committee-assessed Modified Lugano response rate of 89% and a CR rate of 67% (Table). Median progression-free survival was not reached (median follow-up duration 8.95 mo in the efficacy-evaluable population). Conclusions The safety profile of Pola-G-Len is consistent with known profiles of the individual drugs. Response rates at EOI with Pola-G-Len are promising, with high CR comparedwith available R/R FL treatments. (Table Presented)
EMBASE:628867062
ISSN: 1099-1069
CID: 4043542